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Expanded Access Study of RAD001 in Metastatic Renal Cell Cancer Patients Who Are Intolerant of or Who Have Failed Despite Prior Vascular Endothelial Growth Factor Therapy

Primary Purpose

Metastatic Renal Cell Cancer

Status
No longer available
Phase
Locations
International
Study Type
Expanded Access
Intervention
Everolimus
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Metastatic Renal Cell Cancer focused on measuring Expanded access, metastatic renal cell cancer, progression despite VEGF receptors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion criteria:

  • ≥ 18 years old; metastatic renal cancer, intolerant of or failed sunitinib and/or sorafenib
  • Adequate bone marrow function, liver function, renal function
  • Adequate birth control

Exclusion criteria:

  • Previously received RAD001 or other mTOR inhibitors, known hypersensitivity to rapamycin, chronic systemic treatment with corticosteroids or immunosuppressive agents (prednisone ≤ 20 mg/day for adrenal insufficiency OK
  • Topical or inhaled steroids OK)
  • Active bleeding
  • Uncontrolled angina, CHF, heart attack ≤ 6 months, uncontrolled diabetes

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Highlands oncology Group, PA
  • University of Colorado Health Sciences Center/Anschutz Pavillion
  • Cancer Centers of Florida, P.A.
  • MD Anderson Cancer Center - Orlando
  • Indiana University Cancer center
  • The Cancer Institute, St. Joseph Medical Center
  • Henry Ford Health System
  • Missouri Cancer Associates
  • Heartland Hematology-Oncology Associates, Inc.
  • Washington University/Siteman Cancer Center
  • Blumenthal Cancer Center/Carolinas Medical Center
  • Gabrail Cancer Center
  • Cliveland Clinic Foundation
  • Cleo Craig Memorial Cancer & Research Clinic
  • Cancer centers of the Carolinas
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Moncton Hospital
  • QE ll Health Sciences Centre
  • Royal Victoria Hospital
  • Lakeridhe Health Corp - Oshawa
  • Sault Area Hospital - General Site
  • Les Urologues Associes du CHUM
  • Centre Hospitalier Universitaire de Sherbrooke
  • Saskatoon Cancer Center
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative site
  • Novartis Investidative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Royal Bournemouth Hospital
  • British Haematology and Oncology Centre
  • Addenbrookes Hospital
  • CRUK
  • Southampton University Hospital NHS Trust,
  • Oncology & Haematology Clinical Tirals Unit
  • Royal Free Hospital
  • Guy's and St. Thomas' NHS Foundation Trust
  • Royal Marsden Hospital
  • The Christie Hospital
  • Newcastle General Hospital
  • Mount Vernon Cancer Centre
  • St Luke's Wing, Royal Surrey County Hospital
  • Singleton Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 7, 2008
Last Updated
August 18, 2011
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00655252
Brief Title
Expanded Access Study of RAD001 in Metastatic Renal Cell Cancer Patients Who Are Intolerant of or Who Have Failed Despite Prior Vascular Endothelial Growth Factor Therapy
Official Title
An Open-Label, Multi-Center, Expanded Access Study of RAD001 in Patients With Metastatic Carcinoma of the Kidney Who Are Intolerant of or Have Progressed Despite Any AvailableVascular Endothelial Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy
Study Type
Expanded Access

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
This expanded access study is designed to provide RAD001 to patients with MRCC who are without satisfactory treatment alternatives, until RAD001 becomes commercially available.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Renal Cell Cancer
Keywords
Expanded access, metastatic renal cell cancer, progression despite VEGF receptors

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Everolimus

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion criteria: ≥ 18 years old; metastatic renal cancer, intolerant of or failed sunitinib and/or sorafenib Adequate bone marrow function, liver function, renal function Adequate birth control Exclusion criteria: Previously received RAD001 or other mTOR inhibitors, known hypersensitivity to rapamycin, chronic systemic treatment with corticosteroids or immunosuppressive agents (prednisone ≤ 20 mg/day for adrenal insufficiency OK Topical or inhaled steroids OK) Active bleeding Uncontrolled angina, CHF, heart attack ≤ 6 months, uncontrolled diabetes Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Highlands oncology Group, PA
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72764
Country
United States
Facility Name
University of Colorado Health Sciences Center/Anschutz Pavillion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
12801
Country
United States
Facility Name
Cancer Centers of Florida, P.A.
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
MD Anderson Cancer Center - Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Indiana University Cancer center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
The Cancer Institute, St. Joseph Medical Center
City
Towson
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Missouri Cancer Associates
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Heartland Hematology-Oncology Associates, Inc.
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64118
Country
United States
Facility Name
Washington University/Siteman Cancer Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Blumenthal Cancer Center/Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Cliveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Cleo Craig Memorial Cancer & Research Clinic
City
Lawton
State/Province
Oklahoma
ZIP/Postal Code
73505
Country
United States
Facility Name
Cancer centers of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Novartis Investigative Site
City
Malvern
Country
Australia
Facility Name
Novartis Investigative Site
City
Graz
Country
Austria
Facility Name
Novartis Investigative Site
City
Linz
Country
Austria
Facility Name
Novartis Investigative Site
City
Salzburg
Country
Austria
Facility Name
Novartis Investigative Site
City
Vienna
Country
Austria
Facility Name
Novartis Investigative Site
City
Brussels
Country
Belgium
Facility Name
Moncton Hospital
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Facility Name
QE ll Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Royal Victoria Hospital
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Facility Name
Lakeridhe Health Corp - Oshawa
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Sault Area Hospital - General Site
City
Sault Ste Marie
State/Province
Ontario
ZIP/Postal Code
P6A 2C4
Country
Canada
Facility Name
Les Urologues Associes du CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 1N8
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Saskatoon Cancer Center
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
Novartis Investigative Site
City
Brno
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Prague 2
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Prague
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Augsburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Bautzen
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
Country
Germany
Facility Name
Novartis Investigative Site
City
Bremen
Country
Germany
Facility Name
Novartis Investigative Site
City
Chemnitz
Country
Germany
Facility Name
Novartis Investigative Site
City
Dresden
Country
Germany
Facility Name
Novartis Investigative Site
City
Erlangen
Country
Germany
Facility Name
Novartis Investigative Site
City
Essen
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt/Main
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
Country
Germany
Facility Name
Novartis Investigative Site
City
Freiburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Fulda
Country
Germany
Facility Name
Novartis Investigative Site
City
Goslar
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Hannover
Country
Germany
Facility Name
Novartis Investigative Site
City
Jena
Country
Germany
Facility Name
Novartis Investigative site
City
Koln
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
Country
Germany
Facility Name
Novartis Investigative Site
City
Magdeburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Mainz
Country
Germany
Facility Name
Novartis Investigative Site
City
Mannheim
Country
Germany
Facility Name
Novartis Investigative Site
City
Munchen
Country
Germany
Facility Name
Novartis Investigative site
City
Munster
Country
Germany
Facility Name
Novartis Investidative Site
City
Nurnberg
Country
Germany
Facility Name
Novartis Investigative Site
City
Offenburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Oldenburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Recklinghausen
Country
Germany
Facility Name
Novartis Investigative Site
City
Rostock
Country
Germany
Facility Name
Novartis Investigative Site
City
Tubingen
Country
Germany
Facility Name
Novartis Investigative Site
City
Wuppertal
Country
Germany
Facility Name
Novartis Investigative Site
City
Budapest
Country
Hungary
Facility Name
Novartis Investigative Site
City
Beirut
Country
Lebanon
Facility Name
Novartis Investigative Site
City
Alesund
Country
Norway
Facility Name
Novartis Investigative Site
City
Oslo
Country
Norway
Facility Name
Novartis Investigative Site
City
Geneva
Country
Switzerland
Facility Name
Novartis Investigative Site
City
St. Gallen
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Ankara
Country
Turkey
Facility Name
Novartis Investigative Site
City
Istanbul
Country
Turkey
Facility Name
Novartis Investigative Site
City
Izmir
Country
Turkey
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
British Haematology and Oncology Centre
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Addenbrookes Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
CRUK
City
Glasgow
ZIP/Postal Code
G61 1BD
Country
United Kingdom
Facility Name
Southampton University Hospital NHS Trust,
City
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Oncology & Haematology Clinical Tirals Unit
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Guy's and St. Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
The Christie Hospital
City
Manchester
ZIP/Postal Code
M20 9BX
Country
United Kingdom
Facility Name
Newcastle General Hospital
City
Newcastle
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
St Luke's Wing, Royal Surrey County Hospital
City
Surrey
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Singleton Hospital
City
Swansea
ZIP/Postal Code
SA2 8QA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26376939
Citation
Bracarda S, Rottey S, Bahl A, Eichelberg C, Mellado B, Mangel L, Cattaneo A, Panneerselvam A, Grunwald V. REACT expanded-access program in patients with metastatic renal cell carcinoma: real-world data from a European subanalysis. Future Oncol. 2015;11(21):2893-903. doi: 10.2217/fon.15.241. Epub 2015 Sep 17.
Results Reference
derived
PubMed Identifier
21803569
Citation
Grunwald V, Karakiewicz PI, Bavbek SE, Miller K, Machiels JP, Lee SH, Larkin J, Bono P, Rha SY, Castellano D, Blank CU, Knox JJ, Hawkins R, Anak O, Rosamilia M, Booth J, Pirotta N, Bodrogi I; REACT Study Group. An international expanded-access programme of everolimus: addressing safety and efficacy in patients with metastatic renal cell carcinoma who progress after initial vascular endothelial growth factor receptor-tyrosine kinase inhibitor therapy. Eur J Cancer. 2012 Feb;48(3):324-32. doi: 10.1016/j.ejca.2011.06.054. Epub 2011 Jul 29.
Results Reference
derived
Links:
URL
http://www.novartisclinicaltrials.com//webapp/etrials/DiseaseID97/Kidney-Cancer(renal-cell-cancer)-clinicaltrials.go
Description
Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.

Learn more about this trial

Expanded Access Study of RAD001 in Metastatic Renal Cell Cancer Patients Who Are Intolerant of or Who Have Failed Despite Prior Vascular Endothelial Growth Factor Therapy

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